The Effects of Apathy on Different Forms of Fatigue

60 participants with light neuro-cognitive disorders (30 apathetic, 30 non-apathetic) will be recruited from the CMRR (Centre Mémoire Ressources et Recherche) in Nice University Hospital and from the " Fragilily " Platform of the Nice University Hospital.

After verification by the investigator, if they meet the inclusion criteria and sign the informed consent, participants will have to wear an actigraph for one week in order to measure their level of activity.

Afterwards, participants will have to complete assessments and questionnaires to evaluate apathy (Apathy Motivation Index, Apathy Inventory), perceived fatigue (Fatigue Severity Scale, Borg scale), fatigability (6-min walking test, isometric strength test, double task), the stress level (Perceived Stress Scale) and depression (Geriatric Depression Scale).

Regarding the activity level, they will also be asked to perform tasks to evaluate their kinematic movements( through an actigraph), and their particular sensitivity towards effort and reward (through serious game 'Tap-piscine').

The total duration of the evaluation is a maximum of 2 hours.

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Key information

Conditions

Apathy Fatigue Lethargy Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Memoire Ressources et Recherche, CHU de Nice

Nice, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Men or women aged between 65 and 85 years old coming for consultation at the RMC and the Fragility Platform
DSM-5 diagnosis: minor neurocognitive disorders
Subject must read and write in French.
Subject must be registered in the national social security scheme.
Ability to sign free and informed consent.

For the 'apathetic' group:

Presence of apathy/emotional symptoms: at least 2 criteria according to the diagnostic criteria for apathy and a score higher than 8.5 in the MBI affective dimension.

For the 'non-apathetic' group:

Absence of apathy/emotional symptoms: no criteria according to the diagnostic criteria for apathy and a score of less than 8.5 in the MBI affective dimension.

Exclusion criteria

Motor or sensory disabilities likely to interfere with the tests.
Presence of major psychiatric disorders (e.g., schizophrenia, major depressive episode, bipolar disorder)
Patient under guardianship, curatorship or under legal protection

Treatment and study plan

Follow up and Assessment

Other

each patient should wear an actigraph during a week and will be do some tests during 2hours (6min walk, apathy inventory, fatigue severity scale etc...)

Primary outcomes

comparison of Fatigue Severity Scale scores between apathetic and non-apathetic subjects.

Time frame: at inclusion

the minimum score is 9 (worse outcome) and the maximum score is 63 (better outcome)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

FAME 1: The Effects of Apathy on Different Forms of Fatigue

Acronym: FAME1

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Oct 5, 2020
Registry last updated: Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed